Anesthesia, LocalNCT04727515
General Anesthesia, Versus Axillary Block for Ambulatory Hand Surgery: Randomized Prospective Study
A study testing fentanyl 2µg/kg intravenously and maintained with isoflurane and Axillary nerve Block in people with Anesthesia, Local, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims to compare between general anesthesia and axillary nerve block for ambulatory hand surgery regarding postoperative sleep pattern and efficacy. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- fentanyl 2µg/kg intravenously and maintained with isoflurane and Axillary nerve Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Physical Status: ASA I and II Patients after taking written and informed consent
- Body mass index less than 30
Who cannot join
- Refusal of procedure or participation in the study by patients.
- Physical status: ASA III or above
- Subjects presenting with allergy to local anesthetics, alcohol or drug abuse.
- Inability to cooperate mentally retarded patients.
- Bleeding disorders.
- Patients with preoperative obstructive sleep apnea (OSA) or any sleep disturbance.
- Patients with body mass index more than 30.
- Polytrauma patients or emergency operation
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to compare between general anesthesia and axillary nerve block for ambulatory hand surgery regarding postoperative sleep pattern and efficacy.
- Conditions
- Anesthesia, Local
- Being tested
- fentanyl 2µg/kg intravenously and maintained with isoflurane, Axillary nerve Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fentanyl 2µg/kg intravenously and maintained with isofluraneDrug
Anesthesia will be induced using titration of intravenous propofol till loss of verbal contact and fentanyl 2µg/kg intravenously and maintained with isoflurane (end tidal up to 1.5%), oxygen in air 50:50 via a laryngeal mask.
Axillary nerve BlockProcedure or surgery
Axillary block will be performed using ultrasound technique. Patients will receive an axillary block under ultrasound guidance using a linear 5-12 MHz probe.
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia | Experimental | Patients will receive general anesthesia Receives: Drug: fentanyl 2µg/kg intravenously and maintained with isoflurane |
| Axillary Block | Experimental | Patients will receive axillary nerve block Receives: Procedure: Axillary nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting requiring treatment
Measured: First 24 hours postoperatively
Secondary outcomes (2)
Visual analogue scale [VAS]
Visual analogue scale [VAS] will be used to measure pain score at 30 min, 1, 2, 4, 6, 8, 10, 12 and 24 h after surgery. All the study patients will be instructed about the use of the VAS scale before induction of anesthesia (VAS score 0 cm = no pain, VAS score 10 cm = worst possible pain)
Measured: First 24 hours postoperatively
Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index will be used to measure postoperative sleep disturbance. It is formed of 19 items that assess seven clinically derived domains of sleep difficulties (Sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction) over a Likert scale (0-3)
Measured: First 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start1 Jan 2021
- Primary completionApr 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mennatullah Mohammed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04727515
- Sponsor's protocol ID
- FMASU M D 186/2019
- Status last verified
- Jan 2021
- First submitted
- 25 Jan 2021
- Last updated
- 28 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General Anesthesia, Versus Axillary Block for Ambulatory Hand Surgery: Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT04727515
- Acronym / sponsor ID
- FMASU M D 186/2019
- Conditions
- Anesthesia, Local
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare between general anesthesia and axillary nerve block for ambulatory hand surgery regarding postoperative sleep pattern and efficacy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General anesthesia | Experimental | Drug: fentanyl 2µg/kg intravenously and maintained with isofluranePatients will receive general anesthesia |
| Axillary Block | Experimental | Procedure: Axillary nerve BlockPatients will receive axillary nerve block |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Physical Status: ASA I and II Patients after taking written and informed consent
- Body mass index less than 30
Key exclusion criteria (8 listed)
- Refusal of procedure or participation in the study by patients.
- Physical status: ASA III or above
- Subjects presenting with allergy to local anesthetics, alcohol or drug abuse.
- Inability to cooperate mentally retarded patients.
- Bleeding disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fentanyl 2µg/kg intravenously and maintained with isofluraneAnesthesia will be induced using titration of intravenous propofol till loss of verbal contact and fentanyl 2µg/kg intravenously and maintained with isoflurane (end tidal up to 1.5%), oxygen in air 50:50 via a laryngeal mask. | Drug | General anesthesia |
| Axillary nerve BlockAxillary block will be performed using ultrasound technique. Patients will receive an axillary block under ultrasound guidance using a linear 5-12 MHz probe. | Procedure or surgery | Axillary Block |
Primary outcome
Incidence of Postoperative nausea and vomiting
Time frame: First 24 hours postoperatively
Incidence of postoperative nausea and vomiting requiring treatment
2 secondary outcomes
Visual analogue scale [VAS]
Time frame: First 24 hours postoperatively
Pittsburgh Sleep Quality Index
Time frame: First 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fentanyl 2µg/kg intravenously and maintained with isoflurane and Axillary nerve Block in people with Anesthesia, Local, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative nausea and vomiting (time frame: First 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.